Free Usability Engineering Course (Medical Devices - IEC 62366)
Dr. Oliver Eidel
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IEC 62366: Medical Device Usability Engineering
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Updated November 26, 2025
Join us for our free course on medical device usability engineering (IEC 62366) which we've published to YouTube, completely free, no strings attached! You'll learn everything you need to know to bring your medical device to market and achieve compliance with the IEC 62366 which is the standard for usability engineering for medical devices.
00:00 Introduction
01:09 Getting the standard, avoiding the "standards mafia"
02:15 Recap of prior documentation
05:23 Documenting user needs and stakeholders
As mentioned in the video, here's how you get standards from the friendly Estonian site:
https://www.youtube.com/watch?v=IYQGrDmE_Cg
The software I'm using in the video is Formwork, our eQMS software. It's the most affordable eQMS software and perfect for startups. Check it our here:
https://openregulatory.com/
00:00 Introduction
01:09 Getting the standard, avoiding the "standards mafia"
02:15 Recap of prior documentation
05:23 Documenting user needs and stakeholders
As mentioned in the video, here's how you get standards from the friendly Estonian site:
https://www.youtube.com/watch?v=IYQGrDmE_Cg
The software I'm using in the video is Formwork, our eQMS software. It's the most affordable eQMS software and perfect for startups. Check it our here:
https://openregulatory.com/
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I’m a medical doctor, software engineer and regulatory dude. I’m also the founder of OpenRegulatory.
Through OpenRegulatory, I’ve helped 100+ companies with their medical device compliance. While it’s also my job that we stay profitable, I try to dedicate a lot of my time towards writing free content like our articles and templates. Maybe that will make consulting unnecessary some day? :)
If you’re still lost and have further questions, reach out any time!
Through OpenRegulatory, I’ve helped 100+ companies with their medical device compliance. While it’s also my job that we stay profitable, I try to dedicate a lot of my time towards writing free content like our articles and templates. Maybe that will make consulting unnecessary some day? :)
If you’re still lost and have further questions, reach out any time!
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